(87 days)
Not Found
No
The device description focuses on standard electrosurgical technology and monitoring of physical parameters (current, voltage, impedance, temperature) without mentioning any AI or ML algorithms for analysis, decision-making, or control. The "Mentions AI, DNN, or ML" section is also explicitly marked as "Not Found".
No
The device is described as an electrosurgical system intended to ablate and coagulate soft tissue, which is a surgical tool for altering tissue during procedures, not for treating a disease or condition.
No
Explanation: The device is intended to ablate and coagulate soft tissue during surgical procedures, which is a therapeutic function, not a diagnostic one. While it monitors parameters like impedance and temperature, these are for guiding the therapeutic process, not for diagnosing a condition.
No
The device description clearly outlines two hardware components: a Bipolar Coagulator (forceps) and a Bipolar Electrosurgical Generator. The generator includes displays for impedance, current, voltage, power, and temperature, indicating it is a physical device with hardware functionality beyond just software.
Based on the provided information, the AtriCure Bipolar Coagulation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures." This describes a device used on a patient during surgery, not a device used to test samples from a patient outside of the body.
- Device Description: The description details a system that applies radio frequency (RF) energy directly to tissue to cause coagulation. This is a therapeutic or surgical intervention, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AtriCure Bipolar Coagulation System's function is to physically alter tissue during surgery.
N/A
Intended Use / Indications for Use
The AtriCure Bipolar Coagulation System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The AtriCure Bipolar Coagulation System consists of two components: AtriCure Bipolar Coagulator and AtriCure Bipolar Electrosurgical Generator.
The Bipolar Coagulator is substantially equivalent to the predicate Bipolar Forceps in that each consists of a handle connected to a pair of grasping jaws with electrodes on each jaw arm. All the devices utilize the same bipolar Electrosurgical technology, i.e., radio frequency (RF) energy, to coagulate the tissue by heating. The Bipolar Coagulator contains a negative and positive electrode on opposite jaw arms. The function of the Bipolar Coagulator and predicate devices is the same, current flows from a negatively charged pole through the tissue to a positively charged pole. The Bipolar Coagulator is provided as a sterile single patient use device and is provided in a variety of shapes and sizes. The Bipolar Coagulator is constructed with standard biocompatible materials used in medical devices involved in tissue contact.
The Bipolar Coagulator is designed to grasp tissue between the electrodes. When the energy is applied, the tissue touching the electrodes is coagulated. The field of coagulation extends up to 2 mm from the electrode. Area of coagulated tissue will be up to 4 mm in width or up to 60 mm in length. Fully coagulated tissue can be achieved for tissue thickness less than 10 mm.
The Electrosurgical Generator is set to deliver 750 mA of current. As tissue coagulation proceeds the impedance increases. The voltage is set to not exceed 75 Volts. When a voltage of 75 Volts is reached, the impedance increases and current flow decreases with voltage maintained at 75 Volts. Impedance of 400 ohms typically indicates fully coagulated tissue. The unit will display impedance, current, voltage, and power on the front of the generator. The unit will also monitor the temperature of the coagulated tissue and has a range up to 125 degrees Celsius. The surgeon may also use this temperature reading as a point of reference to determine the extent of tissue coagulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The AtriCure Bipolar Coagulation System meets the following performance industrial/international standards:
ANSI/AAMI HF 18
ANSI C101-1992
AAMI ESI-1993
ISO 10993/EN 30993
ISO 11607
ISO 11137
IEC/EN 60601-1
IEC/EN 60601-1+1
IEC/EN 60601-2
IEC/EN 60601-2-2
EN 46001
UL 2601-1
UL 544
UL 498
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K973384, K992931, K993944, K000501, K950286, K951387, K945975, K955001, K963930, K970496, K980110, K974320, K003050, K991517, K993965
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
AtriCure Incorporated
510(k) SUMMARY ATRICURE COAGULATION SYSTEM 510(k) NOTIFICATION K010112 and K01XXXX
KO11722
General Information
AtriCure Medical Corporation Manufacturer: 6033 Schumacher Park Drive West Chester, OH 45069-3863 (513) 755-4100 Fax (513) 755-4108 Est. Req. No. XXXXXXXX
AUG 3 0 2001
Mark L. Friedman, Ph.D. Contact Person: Vice President of Quality Assurance & Regulatory Affairs AtriCure Medical Corporation
[to be added after 510(k) process]
Date Prepared:
Device Description
Class II Classification: AtriCure Bipolar Coagulation System Trade Name: Electrosurgical cutting and coagulation device and Generic/Common Name: Accessories 21CFR878.4400
Predicate Devices
-
- Ethicon Non-Stick Bipolar Forceps (K973384)
-
- Link Technology's Non-Stick Bipolar Forceps (K992931).
-
- The generator accessory is equivalent to the currently marketed Rita Model 1500 Electrosurgical RF Generator, which received clearance under K993944
-
- Somnus Medical Technologies Model S1 Electrosurgical Generator K000501
-
- CardioThoracic Systems MIDCAB/SVH Bipolar Forceps (K963930)
-
- Heartport Inc. Heartport Maze System (K970496)
-
- EndoCare Cryocare Cryosurgical System (K980110)
-
- CyroGen Cardiac Cryosurgical Unit (K974320)
-
- CyroGen Cryosurgical Unit and Accessories (K003050)
-
- Galil Medical Cryo-Hit 200(K991517)
-
- Galil Medical Cryo-Hit (K993965)
1
Indication For Use Statement
The AtriCure Bipolar Coagulation System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
Product Description
The AtriCure Bipolar Coagulation System consists of two components: AtriCure Bipolar Coagulator and AtriCure Bipolar Electrosurgical Generator.
The Bipolar Coagulator is substantially equivalent to the predicate Bipolar Forceps in that each consists of a handle connected to a pair of grasping jaws with electrodes on each jaw arm. All the devices utilize the same bipolar Electrosurgical technology, i.e., radio frequency (RF) energy, to coagulate the tissue by heating. The Bipolar Coagulator contains a negative and positive electrode on opposite jaw arms. The function of the Bipolar Coagulator and predicate devices is the same, current flows from a negatively charged pole through the tissue to a positively charged pole. The Bipolar Coagulator is provided as a sterile single patient use device and is provided in a variety of shapes and sizes. The Bipolar Coagulator is constructed with standard biocompatible materials used in medical devices involved in tissue contact.
The Bipolar Coagulator is designed to grasp tissue between the electrodes. When the energy is applied, the tissue touching the electrodes is coagulated. The field of coagulation extends up to 2 mm from the electrode. Area of coagulated tissue will be up to 4 mm in width or up to 60 mm in length. Fully coagulated tissue can be achieved for tissue thickness less than 10 mm.
The Electrosurgical Generator is set to deliver 750 mA of current. As tissue coagulation proceeds the impedance increases. The voltage is set to not exceed 75 Volts. When a voltage of 75 Volts is reached, the impedance increases and current flow decreases with voltage maintained at 75 Volts. Impedance of 400 ohms typically indicates fully coagulated tissue. The unit will display impedance, current, voltage, and power on the front of the generator. The unit will also monitor the temperature of the coagulated tissue and has a range up to 125 degrees Celsius. The surgeon may also use this temperature reading as a point of reference to determine the extent of tissue coagulation.
The AtriCure Bipolar Coagulation System meets the following performance industrial/international standards.
ANSI/AAMI HF 18 ANSI C101-1992
«
Electrosurgical Devices American National Standard for Leakage Current for Appliances
2
| AAMI ESI-1993 | Safe Current Limits for Electromedical
Apparatus |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993/EN 30993
ISO 11607 | Biological Evaluation of Medical Devices
Packaging for Terminally Sterilized Medical
Devices |
| ISO 11137 | Sterilization of Health Care Products,
Sterilization of Gamma Irradiation |
| IEC/EN 60601-1 | Medical Electrical Equipment - Part 1: General
Requirements for Safety |
| IEC/EN 60601-1+1 | Medical Electrical Equipment - Collateral
Standard: Safety Requirements for Medical
Device Systems |
| IEC/EN 60601-2 | Medical Electrical Equipment - Part 1: General
Requirements for Safety 2: Collateral Standard
Electromagnetic Compatibility - Requirements
and Tests |
| IEC/EN 60601-2-2 | Medical Electrical Equipment - Part 2-2:
Particular Requirements for the Safety of High
Frequency Surgical Equipment |
| EN 46001 | Application of EN ISO 9001 to the Manufacture
of Medical Devices |
| UL 2601-1 | Standard for Safety: Medical Electrical
Equipment |
| UL 544 | Standard for Safety: Medical and Dental
Equipment |
| UL 498 | Standard for Safety: Attachment Plugs and
Receptacles |
Summary
As contained in this 510(k) summary, the AtriCure Bipolar Coagulation System is substantially equivalent to the predicate devices identified.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping profiles facing right. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
Mark L. Friedman, Ph.D. Vice President of Quality Assurance and Regulatory Affairs AtriCure Medical Corporation 6033 Schumacher Park Drive West Chester, Ohio 45069
Re: K011722
Trade/Device Name: AtriCure Bipolar Coagulation System Regulation Number: 878.4400 Regulatory Class: II Product Code: GEI Dated: May 31, 2001 Received: June 4, 2001
Dear Dr. Friedman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Coonisions of the Act. The general controls provisions of the Act include requirements for annual provisions of article from the read manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mark L. Friedman, Ph.D.
This letter will allow you to begin marketing your device as described in your 510ks) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri miding of backan.com vour device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice tor your do need contact the Office of Compliance at additionally 809.10 for in Vitto diagnosus as rices, promotion and advertising of your device, (301) 594-4039. Addinonally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, "Misoranuming by receired to perine Act may be obtained from the Division of Small information on your responsionnes ander the rise in its toll-free number (800) 638-2041 or
Manufacturers International and Consumer Assistance at its toll-free number (8 Manufacturers international and Solass "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Susan Wacker Fox
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page_1 of_f
510(k) Number (if known): K011722
Device Name: AtriCure Bipolar Coagulation System
Indications For Use:
The AtriCure Bipolar Coagulation System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) (Division Sigi-On)
Division of General, Restorative Division of Gical Devices
510(k) Number K011722
(Optional Format 3-10-98)